Humiome® Post LB for Gastrointestinal Symptoms

Overseen By Erin Lewis, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: DSM Nutritional Products, Inc.

Must not be taking: Antibiotics, Prebiotics, Probiotics, Postbiotics

Disqualifiers: IBS, Diabetes, Cardiovascular, others

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Humiome® Post LB, a dietary supplement, can improve bowel movements in individuals with self-reported gastrointestinal (GI) issues, such as bloating and mild cramping. Participants will take either the supplement or a placebo (a substance with no active ingredients) for 8 weeks and report their symptoms. The trial suits those who have 10-20 bowel movements a week and experience mild GI discomfort but do not have diagnosed conditions like Irritable Bowel Syndrome (IBS). As an unphased trial, this study allows participants to contribute to early-stage research and potentially gain new insights into managing GI discomfort.

Will I have to stop taking my current medications?

The trial requires participants to avoid taking prebiotic, probiotic, postbiotics, fiber-rich and dietary supplements, anti-diarrheal, and anti-constipation medications during the study. Other medications may be allowed if they are part of your current habits and approved by the study team.

Is there any evidence suggesting that Humiome® Post LB is likely to be safe for humans?

Research shows that Humiome® Post LB, a type of postbiotic, has been studied for its safety and effectiveness. Postbiotics, which are inactive bacteria and their by-products, can help improve gut health. This treatment includes inactivated strains of Lactobacillus, which have been shown to support gut function.

In past studies, participants generally tolerated Humiome® Post LB well. Researchers continue to investigate its side effects and effectiveness, particularly for managing stomach and digestive issues. Although detailed safety data specific to this trial is not yet available, strong research supports the treatment. With over 40 published studies, it stands as one of the most researched digestive postbiotics, suggesting it is likely safe based on past findings. However, individual reactions can vary, and researchers will monitor participants during the trial to ensure safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Humiome® Post LB because it takes a unique approach to managing gastrointestinal symptoms. Unlike standard treatments that often focus on symptom relief through medication or dietary changes, Humiome® Post LB leverages a postbiotic comprised of inactivated bacteria, specifically Limosilactobacillus fermentum and Lactobacillus delbrueckii. This postbiotic may help balance gut microbiota in a new way, potentially offering benefits beyond what traditional probiotics and medications can achieve. By using these inactivated bacteria, there's also a possibility of avoiding some side effects associated with live probiotics, making it a promising alternative for gut health.

What evidence suggests that Humiome® Post LB is effective for improving bowel movements?

Research has shown that postbiotics, such as Humiome® Post LB, which participants in this trial may receive, might improve gut health by strengthening the intestinal barrier. This treatment includes inactive forms of beneficial bacteria, which may aid digestion. Early results suggest that these postbiotics can improve bowel movements and might ease stomach problems. Although interest in the benefits of postbiotics is growing, further studies in humans are needed to confirm these effects. ^{1 2 3 4 6}

Who Is on the Research Team?

David Crowley, MD

Principal Investigator

KGK Science Inc.

Are You a Good Fit for This Trial?

This trial is for healthy adults who have self-reported gastrointestinal issues and are interested in improving their bowel movements. Participants will be required to keep a study diary, fill out questionnaires, and provide stool samples over an 8-week period.

Inclusion Criteria

Be able to give written informed consent

My BMI is between 18.5 and 29.9.

Be in general good health, as determined by the QI

Exclusion Criteria

I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

Currently consuming a vegetarian or vegan diet

Are planning a holiday over the study period that would alter dietary patterns as assessed by the QI

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Humiome® Post LB (170 mg) or placebo for 8 weeks and complete a study diary, questionnaires, and provide stool samples.

8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Humiome® Post LB

Trial Overview The trial is testing the effects of Humiome® Post LB (170 mg), a supplement taken for 8 weeks, on bowel movement regularity compared to a placebo. The study uses a double-blind design where neither participants nor researchers know who receives the actual supplement or placebo.

How Is the Trial Designed?

Group I: Humiome® Post LB Experimental Treatment 1 Intervention

A postbiotic comprised of inactivated Limosilactobacillus fermentum (CNCM I-2998) and Lactobacillus delbrueckii (CNCM I-4831), together referred to as Lactobacillus LB, and fermented culture medium.

Group II: Placebo Placebo Group 1 Intervention

170 mg/day of micro-crystalline cellulose

Who Is Running the Clinical Trial?

DSM Nutritional Products, Inc.

Lead Sponsor

Trials

98

Recruited

57,600+

Dimitri de Vreeze

DSM Nutritional Products, Inc.

Chief Executive Officer since 2021

MBA from INSEAD, MSc in Civil Engineering from ETH Zurich

Mauricio Adade

DSM Nutritional Products, Inc.

Chief Marketing Officer since 2010

Not available

KGK Science Inc.

Industry Sponsor

Trials

82

Recruited

6,400+

Najla Guthrie

KGK Science Inc.

Chief Executive Officer since 1997

Research career at the Centre for Human Nutrition, University of Western Ontario

Dr. Bibiane Zakaria

KGK Science Inc.

Chief Medical Officer since 2023

MD from an unspecified institution

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06937814

NCT06937814 | The Effect of Humiome® Post LB on Gut ... The goal of this double-blind, randomized placebo-controlled study is to evaluate the effect of an 8-week supplementation of Humiome ® Post LB (170 mg) on ...

2. withpower.com withpower.com/trial/phase-2-gi-issues-5-2025-eb3fe

Humiome® Post LB for Gastrointestinal Symptoms The goal of this double-blind, randomized placebo-controlled study is to evaluate the effect of an 8-week supplementation of Humiome ® Post LB (170 mg) on ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11988720/

A Postbiotic Derived from Lactobacillaceae Protects ... Postbiotics may help strengthen intestinal barrier function. This study assessed the effects of a postbiotic derived from Limosilactobacillus ...

4. dsm-firmenich.com dsm-firmenich.com/content/dam/dsm-firmenich/health-nutrition-care/human-nutrition/pdfs/humiome-biotics/DS_Humiome-Postbiotics_Infographic.pdf

Humiome® Postbiotics The beneficial effects of a postbiotic on health must be confirmed in the target host – for example humans, companion animals and livestock. • The site of ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06937814/the-effect-of-humiomer-post-lb-on-gut-comfort-in-healthy-adult-volunteers

The Effect of Humiome® Post LB on Gut COMFort in ... The goal of this double-blind, randomized placebo-controlled study is to evaluate the effect of an 8-week supplementation of Humiome ® Post ...

6. stratumnutrition.com stratumnutrition.com/human/ingredients/detail/humiome-post-lb/article

Humiome® Post LB As the pioneer in postbiotics with 40+ published studies, Humiome® Post LB is the most clinically researched digestive postbiotic on the market.